Dental practitioners have been aware for years that the repeated handling of a dental tool by gloved or ungloved hands after either the dental practitioner""s or the hygienist""s hands have been in or around the mouths of several different patients without proper sterilization can bring about the spread of contagious diseases. Such contagious or communicable diseases are borne in or on the body fluids and/or tissues which may become attached to the tool or to the exterior surfaces of the gloved or ungloved hands of the dental practitioner or hygienist and then transmitted to the dental tool or implement, such as an intra-oral camera or an ultraviolet curing light, through contact. More recently, the spread of the hepatitis virus and the acquired immune deficiency virus have caused great concern among dental practitioners, dental hygienists and other staff members not only for their patients, but also for their own health and well-being.
The hepatitis virus and the acquired immune deficiency virus have been found to be carried in or on body fluids and/or tissues. In the environment in which dental practitioners, hygienists and other dental staff members work, i.e. inside the mouth, bodily fluids such as saliva, blood, tissues comprising the gum and portions of the teeth, the pulp and root, etc. may potentially transmit the virus form through contact. The process of cleaning and/or repairing teeth by filling caries, performing a root canal procedure or performing restorative or cosmetic dentistry requires the drilling of the teeth and the subsequent scattering of tissue particles and body fluids about the mouth.
During restorative and cosmetic dental procedures, an intra-oral camera may be inserted into the mouth in order to view particular areas within the mouth which are difficult to view, or which can be seen more clearly through the enlargement provided by the monitor attached to the camera. It is also possible that during restorative and cosmetic dental procedures an ultraviolet curing light may be inserted into the mouth of the patient in order to effect the polymerization of the materials utilized in the restorations of the teeth. Some of the particles and/or fluids which potentially carry disease causing organisms may become attached or adhered to the gloved or ungloved hand of the dental practitioner, hygienist or other dental staff member, or to the unsheathed exterior of the intra-oral camera or the curing light. While it is possible to remove and discard the protective gloves, cleaning and sterilizing the exterior of sensitive electronic or narrow band illumination devices such as the intra-oral camera and ultraviolet curing light, between use on different patients has become a serious problem because of their specialized construction.
During dental procedures ranging from cutting and shaping teeth for receiving caps and/or more extensive bridge work and restoration, or the newer cosmetic dentistry using certain polymers to build up or repair the teeth, the ultraviolet curing light may be placed into the interior of a patient""s mouth in close proximity to the tooth or teeth being repaired to effect the curing (or polymerization) of the polymer materials used to restore the tooth or teeth through the use of certain visible lightwaves, i.e. infrared range illumination. The light guide portion of the curing light is placed into the patient""s mouth by the dental practitioner or other staff member in order to effect the desired during of the restoration and repair material.
The problem of disease transmission occurs as the curing light is replaced in its holder for subsequent use, possibly on a different patient, without attention to cleaning and sterilization. Anything the light guide may have come into contact with while in the patient""s mouth may have become attached to the light guide and be transmitted to the next patient on whom the curing light is used. The mere swabbing down of the light guide with a disinfecting solution will not sterilize the curing light, nor will it kill all of the bacteria and virus forms which may have become attached thereto.
The same is true for an intra-oral camera, containing a dental illumination lamp, which is used by the dental practitioner to illuminate and view, on the associated enlarged video monitor, particular areas of the patient""s mouth. Because of the long, narrow tubular construction of the intra-oral camera, and its use either during, intermediate, or subsequent to certain procedures within the patient""s mouth, whatever may have been dislodged in the form of tissue or other tooth material or in the form of bodily fluids may become adhered to the exterior of the intra-oral camera and be transmitted to the next patient on whom the camera may be used. As in the earlier case, the swabbing down of the exterior of the camera body with a disinfecting solution will not sterilize it nor will such swabbing kill all of the bacteria and virus forms which may have become attached thereto. The same will be true for a dental illuminating lamp having similar construction (but without the video capabilities) used for illuminating the work place within the patient""s mouth.
There have been some attempts to provide sterile sheaths for other dental tools, i.e. the dental handpiece or drill. U.S. Pat. No. 4,266,935 [Hoppe] and U.S. Pat. No. 4,728,290 [Eisner, et al.] provide apparatus which are particularly adapted for use with the dental hand pieces in use today. Neither of these devices address the problem of sheathing either the dental curing light or the intra-oral camera with a sterile shield or barrier which prevents pathogenic contamination but permits the visible lightwaves to be emitted without interruption or wavelength shifting.
There have also been attempts to provide sheaths to other dental or surgical implements, which sheaths provide protection against carrying bacteria and/or virus forms onto the exterior surfaces of the particular implements or tools. U.S. Pat. No. 3,794,091 [Ersek, et al.] discloses a sterile sheath for enclosing an elongated surgical illuminating lamp (endoscope) with a light transmitting lens means disposed at the tip of the light transmitting shaft of the lamp structure. The sheath of Ersek is required to be made of a thermoplastic, thermosetting film in order to provide the necessary durability, rigidity and transparency required of the device. Because the sheath may be inserted through fairly long body canals, the sheath is required to exhibit the described characteristics in order to go around or through obstructions, be sufficiently flexible to bend around turns, curves or comers, yet still retain sterile integrity so that the sheath or barrier is not breached.
Another attempt is that made by U.S. Pat. No. 4,757,381 [Cooper, et al.] which describes a sheath for placement over and around a dental camera. However, the Cooper device does not snugly overlie the dental camera and requires attachment by rotationally twisting the sheath and securing it at either end of the dental camera so that the twisted and rotated sheath remains in that position to achieve the prevention of cross-contamination from patient to patient from subsequent uses of the dental camera. The disclosure particularly describes a transparent, clear plastic material which is used to cover the dental camera, but which material does not exhibit any significant elasticity or strength beyond that necessary to resist minimal tearing when the rotating and twisting motion is utilized to secure the sheath in position.
An attempt to provide a transparent cover to alight ray radiation device was made in U.S. Pat. No. 4,804,240 [Mori]. The description indicates that the cover member which covers the light radiator having a hat-shaped elastic body which is capable of transmitting the visible light ray components transmitted into the optical conductor cable. The cover member, although made to be disposable, may be cleaned and disinfected for repeated use. Since the disclosure describes the cover member being made from a transparent and resilient material, and that the cover member as swordguard-shaped portion (as shown in FIG. 2a) which guard retains its shape, the cover member must be non-elastic.
With all of these earlier patents, there lacks an enabling disclosure which describes for an elastic sheath or barrier, which can be superextended over the exterior surface of a dental tool or implement used in dental or medical procedures, that can simultaneously provide the transmissivity for pre-determined light wavelengths while maintaining the cross-contamination barrier for the named pathogens.
The dental curing light and/or the intra-oral camera and illuminating lamp (as well as other medical devices) are not usually thought of as disease transmission devices. They are customarily cleaned with a disinfecting agent, but not sterilized in the normal course. Some of the light guide elements of curing lights or dental cameras and illuminating lamps are detachable for sterilization in an autoclave. However, detachment and reattachment for purposes of sterilization is not believed to occur with the frequency required (between each patient) as is done for other dental tool and instruments which may be sterilized in an autoclave. Hence, sterilizing most likely does not occur between patients and current practice would lead one to believe that only a disinfectant swabbing of the curing light or camera or illuminating lamp may be done between contact with patients to prevent cross-contamination.
In recent years, dental practitioners, hygienists and other in both the dental and medical professions have become increasingly aware of the rapid spread of communicable diseases borne on body fluids and tissues such as may be dislodged and become attached to dental implements or the gloved or ungloved hands of dental or medical practitioners, hygienists, nurses or other staff members during procedures being performed within the body of a patient. In fact, dental and medical practitioners, along with their respective staff members, have been cautioned to protect themselves from infection by using sterile gloves and masks, and to use protective glasses, when practicing dentistry or other dental procedures on their patients. Recently, the rapid spread of the hepatitis virus and the acquired immune deficiency virus has caused significant concern among these practitioners. The American Dental Association and American medical Association, as well as other professional organizations, have strongly urged that health care practitioners and their staff members take additional steps to decrease the chance of spreading disease by cross-contamination through the use of non-sterile implements.
It is, therefore, an object of the present invention to provide a protective pathogen barrier for tools or implements which may be inserted into the mouth or body of a patient which emit light in a pre-determined wavelength to significantly reduce or prevent the spread or cross-contamination of contagious, communicable diseases.
It is a further object of the present invention to provide such a barrier which is disposable after a single use and which is easily applied and removed so that it would have wide-spread acceptance in the dental and medical professions.
It is a another object of the present invention to provide such a barrier which is highly elastic and stretchable, yet tear-resistant, and which is capable of covering the entirety of a variety of elongated, tubular-shaped dental tools or implements which emit lightwaves in predetermined ranges without interrupting or affecting the emission of such light, or the receiving of reflected light, by use of a lens means to provide the required transmissivity of light during dental or medical procedures.
Other objects will appear hereinafter.
The present invention may be described as a disposable pathogen barrier for placement over and in proximate contact with a light emitting means for significantly reducing the spread of communicable and infectious diseases which may be transmitted by or through contact with human body fluids and tissues during a first and subsequent use of said light emitting means in conjunction with the treatment of two or more patients eliminating the need for repeated sterilization of said light emitting means between such uses for two or more patients. The disposable pathogen barrier is comprised of an elongated tubular sleeve terminating in a substantially circular aperture at a first end thereof of sufficient size for fitting over said light emitting means and preventing contamination of the outer surfaces of said light emitting means. The barrier also has sufficient elastic material memory to maintain itself in position covering said light emitting means without slippage until manual removal.
The barrier, in a first embodiment, has an optically transmissive second end which overlies in juxtaposition and covers the illumination means of said light emitting means. The optically transmissive second end of said barrier freely passes light rays from said light emitting means without distortion, interruption or light wavelength shifting.
Although the optically transmissive second end of said barrier in the first embodiment may be made from the same material as the sleeve, the optically transmissive second end, in a second embodiment, may be further comprised of an optically clear film inserted into a substantially circular die cut in said sleeve proximal said second end and positioned along the interior surface of said barrier by an adhesive bond around the periphery of said die cut. The adhesive positions the clear film and provides a seal for preventing contamination of the surface of the light emitting means. The optically clear film having a thickness in the range between 0.025 and 0.080 inches.
The barrier may be made from an elastomeric or elastic material, natural or man-made, or combinations thereof. The barrier also exhibits sufficient deformability, toughness and tear-resistance to stretch over said light emitting means and to withstand pulling and stretching during application and removal. The light emitting means may be any one of the group consisting of intra-oral cameras and dental material curing lamps.